![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Synedgen Gets FDA Clearance for Mouth Sore Rinse
Synedgen Gets FDA Clearance for Mouth Sore Rinse
Synedgen has received FDA 510(k) clearance for its Synvaza over-the-counter mouth sore and wound rinse.
The treatment helps to manage pain and spur healing for mouth sores and ulcers, including traumatic ulcers and surgical injuries.
A clinical trial of the product, which is regulated as a medical device, showed that patients experienced decreased pain from ulcerative oral lesions and decreases in oral soreness when drinking, swallowing, eating, talking and sleeping.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct